title: Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial.
abstract: BACKGROUND
  Recent studies have shown that both steroids and angiotensin-converting enzyme (ACE) inhibitors improve kidney survival and decrease proteinuria in patients with immunoglobulin A nephropathy. In this study, we aim to investigate whether the addition of steroids to ACE-inhibitor therapy produces a more potent antiproteinuric effect and better protection of kidney function than an ACE inhibitor alone.
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  Patients with biopsy-proven immunoglobulin A nephropathy with proteinuria of 1 to 5 g/d of protein.
  
  
  METHODS
  63 patients were randomly assigned to either cilazapril alone (ACE-inhibitor group; n = 30) or steroid plus cilazapril (combination group; n = 33).
  
  
  METHODS
  The primary end point was kidney survival, defined as a 50% increase in baseline serum creatinine level.
  
  
  RESULTS
  After follow-up for up to 48 months, 7 patients in the ACE-inhibitor group (24.1%) reached the primary end point compared with 1 patient (3%) in the combination group. Kaplan-Meier kidney survival was significantly better in the combination group than the ACE-inhibitor group after 24 and 36 months (96.6% versus 75.7%, 96.6% versus 66.2%; P = 0.001). Urine protein excretion significantly decreased in patients in the combination group compared with the ACE-inhibitor group (time-average proteinuria, 1.04 +/- 0.54 versus 1.57 +/- 0.86 g/d of protein; P = 0.01). Multivariate analysis showed that combination treatment (hazard ratio, 0.1; 95% confidence interval, 0.014 to 0.946) and time-average proteinuria (hazard ratio, 14.3; 95% confidence interval, 2.86 to 71.92) were independent predictors of kidney survival.
  
  
  CONCLUSIONS
  Small sample size, a single center, and slight imbalances at baseline.
  
  
  CONCLUSIONS
  Our results suggest that the addition of steroid to ACE-inhibitor therapy provided additional benefit compared with an ACE inhibitor alone. However, this was a pilot study with a small number of participants achieving the end points, and thus further validation is necessary.
authors.affiliation: Renal Division, Department of Medicine, Peking University First Hospital, Institute of Nephrology, Peking University, No. 8 Xishiku Street, Xicheng District, Beijing, People's Republic of China.
authors.forename: Jicheng
authors.initials: J
authors.lastname: Lv
authors.forename: Hong
authors.initials: H
authors.lastname: Zhang
authors.forename: Yuqing
authors.initials: Y
authors.lastname: Chen
authors.forename: Guangtao
authors.initials: G
authors.lastname: Li
authors.forename: Lei
authors.initials: L
authors.lastname: Jiang
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Singh
authors.forename: Haiyan
authors.initials: H
authors.lastname: Wang
mesh_terms: D000305:Adrenal Cortex Hormones / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D001706:Biopsy; D017315:Cilazapril / Q000009:adverse effects / Q000627:therapeutic use*; D003404:Creatinine / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D005922:Glomerulonephritis, IGA / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007668:Kidney / Q000473:pathology / Q000503:physiopathology; D008297:Male; D015999:Multivariate Analysis; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use*; D011507:Proteinuria / Q000097:blood / Q000188:drug therapy / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000806:Angiotensin-Converting Enzyme Inhibitors; D017315:Cilazapril; D003404:Creatinine; D011241:Prednisone